CN106232170B

CN106232170B - System and method for detecting and preventing wet injection

Info

Publication number: CN106232170B
Application number: CN201580019391.4A
Authority: CN
Inventors: 杰夫·贝克; 保罗·冯·德·波尔; 弗兰西斯·迈克·希莫尔
Original assignee: Noble International LLC
Current assignee: Noble International LLC
Priority date: 2014-02-17
Filing date: 2015-02-17
Publication date: 2022-07-29
Anticipated expiration: 2035-02-17
Also published as: EP3107615A1; US10729852B2; WO2015123688A1; EP3107615A4; US20210016007A1; US20170049965A1; CA2940053A1; EP3107615B1; CN106232170A

Abstract

In one embodiment, a drug delivery system is provided. The medicament delivery system includes a container for storing the medicament prior to use, the container having a first end and a second end, an injection member in fluid communication with the container, an advancement mechanism coupled to the container and configured to deliver the medicament from the container through the injection member when the advancement mechanism is activated. The medicament delivery system further comprises at least one detection element connected to the system, wherein in a first mode of operation of the system medicament is delivered through the injection member and in a second mode of operation of the system medicament is not delivered through the injection member and the mode of operation is dependent on an output from the at least one detection element.

Description

System and method for detecting and preventing wet injection

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. provisional patent application No. 61940601 filed on day 2, month 17, 2014 and contains the contents of that application by reference.

Technical Field

Embodiments of the present invention are directed to systems and methods for improving compliance of injectable drugs during administration.

Background

Syringe devices based on manual handling existed since the middle of the 19 th century. These devices are designed to have a single purpose, i.e. to perform subcutaneous injections through a hollow tubular needle attached to the injector device. These syringes are simple mechanical systems that cannot apply elaborate hydrodynamics or incorporate advanced digital technology.

A pre-filled syringe is a primary drug container and delivery system for administration of an injection therapy to a health care worker or patient. Pre-filled syringes are typically provided to medical customers in a "ready-to-fill" mode for filling and packaging a dose of an injectable drug or vaccine. The primary container is subject to industry and pharmaceutical standards to ensure that the formulation of the drug is protected for an extended period of time.

Autoinjectors are used by patients to self-administer drugs outside of medical systems. Auto-injectors are designed to allow a user to automatically administer a drug contained in a pre-filled injector upon actuation of a button. The auto-injector market is one of the fastest growing areas in the medical device market. Automatic injection devices or "fountain pen" devices have gained increasing popularity in recent years for home use in single or multiple dose self-administration. These automatic injection devices were first designed to accomplish two basic purposes: convenience and automation of drug delivery for non-hospitalized patients. Typically, these automatic injection devices are mechanical spring-loaded devices that are used to push a component of the device to move the drug through the hollow cannula needle to the body tissue of the patient.

Automatic injection devices typically provide a way to self-inject a drug. The size and operation of these automatic injection devices can be painful for a patient, whether they are the first time they are injected or have previously been injected. The fear and anxiety associated with these currently available self-injection devices, particularly automatic injection devices, may result in incomplete administration of a dose of medication, failure to administer any portion of a dose of medication, or inadvertent pricking of the device on itself with the needle, which in some cases, if the needle becomes infected, may result in undesirable disease transmission. In addition, during an injection, the medicament is often wasted when the injection device is removed from the patient part-way before the full dose of medicament is injected into the patient. Therefore, the inability to meet the therapeutic requirements is also a major problem with injection devices.

Automatic injection devices are not capable of adjusting whether the medication has been delivered to the patient or whether the medication is delivered to a correct location. Most automatic injection devices are not capable of incorporating advanced digital technology. There is therefore a need for an injection device that can be safely and efficiently used by a patient, which does not require medical experience for preparation and self-injection of the drug, and which is improved to the level required for treatment.

Disclosure of Invention

The inventors have found that the prior art can be improved in several respects. The inventors have found that prior art injection devices and syringes lack some safety and convenience features, are also uneconomical, and do not meet the therapeutic requirements. Often during an injection, the needle is removed from the patient before the injection is complete (or the injection is initiated before the needle has not been inserted into the patient) and the needle is removed before the full dose of medication is injected into the patient, resulting in a reduction in the rate at which treatment is required, with increased medication and economic waste. Accordingly, the inventors herein have set forth a drug delivery system and method that addresses many of the above-mentioned problems in the prior art.

Drawings

More particular description than the brief description above will be rendered by reference to specific embodiments which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments and are not therefore to be considered to be limiting of its scope, the embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

FIG. 1 shows a cross-sectional view of one embodiment of a drug delivery system.

Figure 2 shows a cross-sectional view of another embodiment of a drug delivery system.

Figure 3 shows a cross-sectional view of yet another embodiment of a drug delivery system.

Fig. 4A-4B show cross-sectional views of another embodiment of a drug delivery system in a first mode of operation and a second mode of operation, respectively.

FIG. 5 shows an enlarged view of one embodiment of a container.

Figure 6 shows an enlarged view of another embodiment of a container.

FIG. 7 is a cross-sectional view of one embodiment of a drug delivery system in use, with an injection component positioned in a target tissue of a patient during an injection.

Fig. 8 is a cross-sectional view of the embodiment of the drug delivery system shown in fig. 7, wherein the drug delivery system is moved such that the injection member is removed from the tissue of the patient during the injection process.

Detailed Description

For the purposes of promoting an understanding of the principles and operation of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.

Defining:

for example, "preset" as used herein includes, but is not limited to, a value or a range of values associated with an event related to the use or operation of the device. These values may include, but are not limited to, critical values, maximum values, baseline values, or range values, as desired or undesired in a particular example. Examples of preset values include, but are not limited to, preset directional values, preset time values, or preset contact values, and other preset values described herein refer to values that are used as reference values in connection with, for example, a value, signal, or indication detected by a sensing element of the drug delivery system. The predetermined value may comprise an optimum value, or a sub-optimum value, or any value in between. In one example, one preset time value may comprise 1 minute to reset the system and an additional preset time value may comprise 10 seconds to reset the system.

The term "couple" or "couples" as used herein includes, but is not limited to, being directly or indirectly attached to, proximate to, in contact with, partially or fully attached to, and/or in close proximity thereto. The term "value" as used herein may refer to a specific value or a range of values.

It should be noted that the terms "first," "second," and the like as used herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The terms "a" and "an" do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. The modifier "about" used in connection with a quantity is inclusive of the stated value and has the meaning dictated by the context. It is noted that all ranges disclosed in this specification are inclusive and independently combinable. Furthermore, to the extent that the terms "includes," including, "" has, "" having, "" contains, "" containing, "" involving, "and variations thereof are used in either the detailed description and/or the claims, such terms are intended to be inclusive in a manner similar to the term" comprising.

Notwithstanding that the numerical ranges and parameters setting forth the broad scope are approximations, the numerical values set forth in the specific non-limiting examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. It should also be understood that all ranges disclosed in this specification include any and all subranges subsumed therein. As a non-limiting example, a range of "less than 10" can include any and all subranges between a minimum value of 0 (including 0) and a maximum value of 10 (including 10), i.e., any and all subranges having a minimum value equal to 0 or greater than 0 and a maximum value equal to 10 or less than 10, for example: 1 to 7.

The term "injection component" as used herein includes, in one example, a needle or other component that is used to pierce the skin of a user and inject a fluid into the user. Various propulsion mechanisms can be used to propel the system described herein; however, in order to achieve a slow and controlled movement, for example an electromagnetic or electric propulsion mechanism can be used. This is not intended to be limiting and, for example, "solenoid" includes, but is not limited to, a solenoid with an electromagnetic shaft that interacts with a plug or piston when activated. Various types of propulsion mechanisms known in the art, as well as other propulsion mechanisms described herein, may also be used, including, but not limited to, ACME/lead screw, spring, compressed air, magnet, flexinol wire, solenoid, standard dc motor, pancake motor, and other motors, peristaltic pumps, and any other related propulsion mechanism. The propulsion components described herein refer to the components of the system that are used to activate the propulsion mechanism. Examples of propulsion components include, but are not limited to, buttons, switches, and any other type of propulsion component known to those skilled in the art.

In one embodiment, the subject invention includes a drug delivery system, wherein the system includes a container for storing the drug prior to use. The container includes a first end and a second end, an injection component in fluid communication with the container, an advancement mechanism coupled to the container and upon activation of the advancement mechanism, medication is administered from the container through the injection component, and the at least one detection component is coupled to the system. Wherein in a first mode of operation of the system, medicament is administered through the injection component and in a second mode of operation of the system, medicament is not administered through the injection component and the mode of operation is dependent on an output generated from the at least one sensing element.

In a further embodiment, the system may include a controller for monitoring output information from the at least one sensing element, the controller operating the system in the first or second operating mode based on the received output information. In one embodiment, the activation and/or deactivation of the propulsion mechanism may be electronically controlled by the controller based on output information generated from the at least one sensing element.

In a further embodiment, the system may comprise a piston, wherein the piston interacts with the advancing mechanism such that when the advancing mechanism is activated, the piston passes through the container from a first position of the piston to a second position of the piston, such that when the piston moves from the first position to the second position, the medicament is administered through the injection component. In said first position of the piston, the injection has not yet begun and no medicament is administered to or through the injection member. In said second position of the piston, the medicament dose is fully administered from the container through the injection member. The administration of the medicament may be incomplete at any point between said first and second positions of the piston. In a single dose embodiment of the system, wherein the entire drug content of the container corresponds to one dose of drug, the second position of the piston is located at the bottom of the container. In a multi-dose embodiment of the system, wherein the container contains a plurality of complete doses of the medicament, the second position of the piston is at a predetermined position between the top and bottom of the container. In an intermediate position of a multi-dose container, a full dose of medicament is provided.

The system may further comprise at least one first sensing element. The first sensing element is capable of sensing and providing an output based on the position of the piston relative to the container or based on the position of the piston relative to an object external to the system. In a further embodiment, the system comprises a second sensing element. The second sensing element may be connected to the piston such that the second sensing element is able to sense the position of the first sensing element, or the first sensing element is able to sense the position of the second sensing element such that the position of the piston is able to be sensed and an amount of drug administered through the injection component is able to be sensed. In another embodiment, the container is covered and supported by a cover, and the at least one first or second sensing element of the system is capable of sensing and providing an output based on the position of the piston relative to the cover. In a particular embodiment, as a non-limiting example, the second sensing element may include one or more magnets and the first sensing element may sense the one or more magnets. Thus, in one non-limiting embodiment, if the second sensing element is coupled to the piston while the first sensing element is coupled to the container housing (i.e., the first chamber or the second chamber), or a housing for receiving the container, or an object external to the system, the movement of the piston relative to the first sensing element will be monitored by the first sensing element. Thus, the position of the piston can be sensed and thus the amount of drug delivered and/or left behind can be determined. In another non-limiting example, the first or second sensing element may comprise a Linear Variable Differential Transformer (LVDT) capable of sensing displacement of, for example, a piston, a reservoir and/or an injection member.

In an alternative embodiment, a medicament delivery system is provided, wherein the system comprises a container for storing a medicament prior to use. The container includes a first end and a second end, an injection member in fluid communication with the container, an advancement mechanism coupled to the container and adapted to deliver the medicament from the container through the injection member when the advancement mechanism is activated, and a timing element. The system may include a controller, wherein the timing element may be an element of the controller. The timing element may detect, record, or a combination of detection and recording of the condition of the drug delivery system, for example, the timing element may detect when the system is initially activated, when the drug is being delivered through the injection member, when the drug is being delivered from the reservoir, when the advancement mechanism is activated, and/or when the advancement member is deactivated, for example, in a non-limiting embodiment. The time detected and/or recorded may be compared to a predetermined time of movement of the advancing mechanism to complete the administration of the medicament or to the time of movement of the piston relative to the second chamber of the container to complete the administration of the medicament from the container. For example, in one embodiment, the system may detect a wet injection (wet injection) if the time from system start to piston stop motion is detected to be less than a predetermined and stored time in the system for completing an injection from system start to when the piston stops motion after the injection is fully delivered to the patient. According to this embodiment, no separate sensing element is required for monitoring the wet injection.

In a first mode of operation of the system, the medicament is administered through the injection member, in a second mode of operation of the system, the medicament is not administered through the injection member, and said mode of operation is dependent on the output from said at least one sensing element.

In a further embodiment, the system may include a controller to monitor output from the at least one sensing element, the controller being responsive to receipt of the output to operate the system in one of the first or second modes of operation. In one embodiment, the controller is capable of electrically controlling the starting and/or stopping of the starting of the propulsion mechanism based on the output information generated by the at least one detection element.

In a further embodiment, a medicament delivery system is provided, wherein the system comprises a container for storing a medicament prior to use. The container includes a first chamber for containing the medicament, a piston connected to the first chamber, a second chamber in which the first chamber is embedded, an injection member connected to a lower portion of the first chamber and movable through an injection opening in the first chamber, and a spring positioned between the first chamber and the second chamber. The system further includes at least one sensing element coupled to the container and providing an output based on a condition sensed by the at least one sensing element, a propulsion mechanism coupled to the system, the first chamber moving in a first direction relative to the second chamber when the propulsion mechanism is activated, the spring being loaded, the injection member extending from the second chamber, the piston moving relative to the first chamber to administer the medicament through the injection member, such that when the first chamber moves in a second direction relative to the second chamber, the spring is released and the injection member retracts into the second chamber to prevent inadvertent contact with the injection member. In a first mode of operation of the system, the medicament is administered through the injection member, in a second mode of operation of the system, the medicament is not administered through the injection member, and the mode of operation is dependent on the output generated by the at least one sensing element.

The at least one sensing element may be provided in or associated with any part of the system, including but not limited to a lower portion of the container, or a portion of a chamber of the system, a portion of an injection component, a propulsion mechanism, a plunger, an interior surface of the container, or an exterior surface of the container, in non-limiting examples.

In a further embodiment, the at least one detection element comprises a contact sensor, wherein the output information generated by the at least one detection element depends on whether contact is made between the contact sensor and the patient. The touch sensor may be provided at a lower portion of the container such that removal of the container from the user does not transmit a touch signal to the processor. In another non-limiting embodiment, the contact sensor may be placed on a cap that houses the container, or on a portion of the injection component, or on the piston. The contact sensor enables the system to detect whether the container or system has been removed from a target injection site of a patient during an injection, thereby preventing or minimizing the likelihood of a wet injection. Generally speaking, a sensor may be associated with the container or system and may indicate or detect the amount of drug in the container. Specific, non-limiting examples and embodiments of sensors for making these determinations are described more fully below.

Wet injection (wet injection) may include the situation where the injection member is removed from the patient while the injection is in progress (i.e., the drug flows out through the injection member as it is removed from the patient), thus wasting the drug and preventing the patient from receiving the proper dose of drug. Other wet injection situations occur before the injection member is inserted into the patient's body, and before injection begins, wherein the system is activated and the drug is delivered into the surrounding environment through the injection member. In one embodiment, when the system is in a second mode of operation and the piston is between the first position and the second position, a sensing element generates an output indicating that an incomplete administration of the medicament has occurred (i.e., a wet injection has been detected). Thus, in embodiments of the invention, one or more sensing elements are capable of sensing the position of various parts of the system relative to other parts, such as described herein, in one non-limiting example, a first sensing element associated with a first or second chamber of the container is capable of sensing the orientation and position of a second sensing element associated with the piston. This information can be used to identify the amount of drug left in the container or the amount of drug delivered from the container. In another embodiment, if the injection member has been removed from the patient and the piston is in motion, the system will detect that a wet injection is occurring or is about to occur and then the drug delivery from the reservoir is stopped.

In one embodiment, the at least one detection element is coupled to the injection component, wherein the at least one detection element comprises a sensor and the sensor is configured to detect a pressure difference between the pressure of the air and the skin pressure of the patient (e.g., a pressure sensor) to thereby detect whether the injection component has been inserted into the patient. If the at least one sensing element detects that the injection member is not in the patient and the advancing member has been activated, the sensor generates an output to stop the activation of the advancing member, or to stop the movement of the piston, or to prevent the flow of drug through the injection member in any of the methods described herein, thereby preventing a wet injection.

In another embodiment of the system, the drug delivery system comprises an electrical current through the injection member such that the second mode of operation is initiated when a change in an electrical characteristic is detected. In a further embodiment, a change of a measuring unit on the injection component is detected by the detection element when the injection component is inserted into or removed from the patient, and wherein the operating mode depends on a value of said measuring unit. Examples of electrical characteristics described herein include, but are not limited to, electromagnetic characteristics, ultrasonic, sonar, and temperature characteristics. In some cases, the detection element may be a part of, or associated with, the injection component. In other cases, the injection component may be the detection element. Thus, in a non-limiting embodiment, the electrical characteristic can be detected by the injection component.

In a further embodiment of the drug delivery system, the at least one detection element may comprise a light sensor. The output from the at least one detection element may be dependent on whether a light is projected from the container and, in one example, detected by the light sensor, thereby being able to indicate that a wet injection may occur or is occurring. In still further embodiments, the system may be configured such that if the light is projected from the container, the system will stop or halt the flow of the medicament.

In a further embodiment, the at least one sensing element may comprise a temperature sensor, in a non-limiting embodiment capable of identifying or sensing the temperature of the patient's skin or the temperature in the body. The output information generated by the at least one sensing element may be dependent on a temperature sensed by the temperature sensor. In one particular embodiment, the system operates in the first mode of operation when the temperature sensor detects a patient temperature of between 87 and 100 degrees Fahrenheit. In another embodiment, the system operates in the first mode of operation when the temperature sensor detects a temperature between 90 and 93 degrees Fahrenheit. In a further embodiment, the system may comprise a contact sensor and a temperature sensor, wherein the mode of operation of the system is dependent on the output information generated by the at least one detection element based on the contact sensor and the temperature sensor. In one non-limiting example, the system may require that contact be detected by a contact sensor and that a particular range of degrees of temperature be detected by a temperature sensor, thereby detecting that the system is in contact with a patient, rather than, for example, an inactive object, thereby preventing wet injection.

In a further embodiment, the at least one detection element comprises a distance sensor for detecting the distance of the system to a target area on the patient's body. The mode of operation of the system may depend on the output information generated from the at least one detection element as a function of the distance of the system to the target area. The target area of the patient may include a desired injection area and an area adjacent to the desired injection area. The target area of the patient may depend, for example, on the type of drug being injected. For example, when multiple injections are made over an approximate area of a patient, the target area of the patient may be changed from one injection to the next as needed for movement of the injection area in order to reduce injury and/or pain in that particular area.

In one embodiment, the reservoir may include a current directed through the reservoir for detecting the amount of drug contained in the reservoir. This is useful, for example, when a wet injection occurs and is detected by the system, it is necessary to meter the amount of drug remaining in the container to determine how much drug has been administered to the patient and how much remains in the complete dose. In some embodiments, once a wet injection is detected, the user must replace the container of the system with a new container and/or a new needle to complete the dosage of the drug. Thus, identifying the amount of drug remaining in the container is very helpful in determining the amount of drug needed to complete the requested dose. The system then identifies the amount of medicament needed in the new container to complete the injected dose.

In another embodiment, the system may include one or more valves. The one or more valves open and close based on the output information generated by the at least one sensing element. In one case, when the valve is open, the drug is administered through the injection member and when the valve is closed, the administration of the drug through the injection member is stopped.

The injection component may be connected to the container such that it extends from the container when the propulsion mechanism is activated and retracts into the container after use. It is contemplated herein that a number of different variations of retraction mechanisms may be used. For example, a pressure spring may be connected to the one second chamber (described in a further embodiment discussed below) of the system and to a part of the first chamber, wherein the spring may be used to move the first chamber in a second direction relative to the second chamber to retract the injection member. Another embodiment may comprise a pushing mechanism attached to or connected to said piston or said first chamber for retracting the first chamber. Retracting the injection member may provide a safety mechanism to prevent the user from pricking himself with the injection member before, during or after the injection. In one embodiment, retraction of the injection component may occur: if the injection part is extended from the container before the injection or drug delivery is started; if the injection member is removed from the patient during the injection process; and/or after an injection has been completed.

In some described embodiments of the invention, the injection member extends from the container when the propulsion mechanism is activated and the system is in the first mode of operation and retracts into the container when the system is in the second mode of operation.

In a further embodiment of the system, a protruding member is provided which blocks (locks or covers) the injection member when it is retracted into the container, thus preventing the injection member from protruding. This safety feature prevents the user from being needlessly pricked by the injection component.

In a further embodiment, a locking mechanism is coupled to the propulsion mechanism, wherein the locking mechanism is activated based on the output generated by the at least one detection element (activation of the locking mechanism may include locking and unlocking of the locking mechanism, depending on the output received). When the locking mechanism is in a locked position, the administration of the medicament through the injection member is prevented, and when the locking mechanism is in an unlocked position, the medicament is administered through the injection member. The locking mechanism controls the start of the drug delivery, i.e. whether the system will enter a second mode of operation.

In a further embodiment, the system comprises a stopping mechanism, wherein the stopping mechanism is activated in response to the output generated by the at least one sensing element, and in a further embodiment in response to the output generated by the at least one sensing element and the at least one sensing element, wherein the stopping mechanism is configured to stop the administration of the drug after the advancing mechanism is activated and before the administration of the drug is completed. In one embodiment, the drug delivery is completed after the full dose has been delivered through the injection component. The system may be adapted to perform both single and multiple dose injections. In a single dose injection the container is emptied when the full dose has been administered, whereas in a multiple dose injection the container may contain further subsequent doses of medicament even after one full dose has been administered through the injection member. The various ways of stopping the operation of the mechanism include, but are not limited to: stopping a motor of the system; stopping operation of a spring of the system or other element of the system; or stop the delivery of the medicament from the container in a stopped movement, as well as in a variety of other mechanical or electromechanical ways known to those skilled in the art.

In one embodiment, a motor is used to drive the system. The processor may be connected to the piston and the motor is connected to the first chamber and/or the piston such that when the detection element detects that there is no contact between the patient and the detection element, the processor stops the motor from moving the first chamber in the first direction relative to the second chamber and/or from moving the piston in the first direction relative to the first chamber, thereby preventing the drug from being administered through the injection component. As an adjunct or alternative to the detection element used to detect the presence or absence of contact between the user and the container or the system, other methods of contact detection known in the art are also contemplated by the present invention, including but not limited to, a contact sensor or a contact switch. In a further embodiment, as discussed in the present invention, at least a first sensor element and a second sensor element can be used to detect the amount of medicament remaining in the container, whereby an output can be generated from said first or second sensor element, the mode of operation of the system depending on said output. In one embodiment, the mode of operation of the system may depend on both output information from the sensing elements and output information from one or more sensing elements of the system. Thus, in one embodiment, the position of the injection component (relative to the patient) and the amount of medicament in the container can be detected or sensed, which results in a determination of the operational mode of the system.

In another embodiment, the system may further comprise a current through the injection component such that the second mode of operation is initiated when a change in the electrical characteristic is detected. Examples of electrical characteristics described herein include, but are not limited to, electromagnetic characteristics, ultrasonic, sonar, and temperature characteristics. In a further embodiment, a change in a measurement unit on the injection component may be detected when the injection component is inserted into or removed from the patient. The mode of operation of the system may depend on a value of the measurement unit being detected.

In one embodiment, the system provides a restorative process once a wet injection is detected. The amount of drug remaining to complete a dose of drug may be identified. In one embodiment, after a wet injection is detected, depending on the amount of displacement of the piston in the container, an amount of drug remaining in the container may be identified and this may be sensed by the first and second sensing elements, as described herein, or by other methods described herein. In another embodiment, when the system is in said second mode of operation and the piston is between said first and second positions, the number of revolutions of the motor may be indicative of the amount of medicament remaining in the container. The motor may be activated in a variety of ways, including by turning on the propulsion mechanism, by the user touching a button or switch, or automatically through a series of steps, or by any other method known to those skilled in the art.

In another embodiment, the system may include a flow sensor for sensing the amount of medication being administered through the injection component and may therefore provide information relating to the amount of medication remaining in the container. In non-limiting examples, the flow sensor may be located on or in close proximity to the injection component, or in the container. In a further embodiment, the amount of medicament remaining in the container can be identified by a visual indicator of the system. The visual indicator may comprise a window for the user to see e.g. the amount of medicament remaining or the position of the piston. In another embodiment, the visual indicator comprises a series of lines or indicia on the container, a light or a screen associated with the system, or a change in color of at least a portion of the system or container to indicate the amount of medication remaining in the container or to indicate that a dose of medication has been completely administered from the container.

In one embodiment, once the system is in the second mode of operation, the system is automatically reset or, in one embodiment, is set to be manually reset to enable any remaining medicament in the container to be administered through the injection component. In a non-limiting example, the resetting may include, but is not limited to, unlocking of the locking mechanism, deactivation of the stopping mechanism. In a particular example, the locking mechanism can be automatically reset to the unlocked position after a predetermined period of time. This predetermined period of time may be set by, for example, a user of the system prior to using the system, or may be predetermined by the manufacturer of the system. In one embodiment, the predetermined period of time may be in the range of 1 second to 10 minutes; or in a further embodiment, may be in the range of 5 seconds to 5 minutes.

In another embodiment, following the second mode of operation, the system can be reset, wherein the container can be replaced by a new container, in order to complete a dose of medicament or in order to start a new dose of medicament. In yet another embodiment, and by way of non-limiting example, the system may be reset to begin the first mode of operation when the propulsion mechanism is activated or upon insertion of a container. The resetting of the system may be done automatically or manually.

In a further embodiment, the system described herein can be activated by a peristaltic pump advancing mechanism whereby the drug can be retained in a flexible container, a roller attached to a rotor pressing against the flexible container causing the drug to be removed from the container and administered through the injection unit. When the rotor rotates, the squeezed portion of the container is blocked by the roller and the medicament in the container is pumped out and moved through the tube and the injection member. Once the container is opened to its natural state, a flow of liquid is introduced into the pump. In some embodiments, two or more rollers may block the reservoir and form a blocked one of the drug packs between the rollers. In one example, the drug may then be transported to the outlet of the pump.

In certain embodiments, the detection element described herein may be integrated with, associated with, or on the injection component.

In one embodiment, a method of preventing a wet injection from occurring during an injection of a patient using a drug-delivery system comprising an injection component and a first container containing a dose of a drug is provided. The method includes sensing an amount of medication in the container such that an incomplete medication dose can be detected; detecting that the injection member is removed from the patient when a dose of medication is not completed; stopping the flow of the drug through the injection component when the injection component is removed from the patient and the dose of the drug is not completed; and provides an indication to the patient to resume the system to complete the drug dose.

In a further embodiment, removal of the injection component from the patient can be detected by visual observation, one or more sensors, a change in electromagnetic properties, or one or more switches. In one embodiment, the flow of drug through the injection component may be stopped by one or more valves, a gate, or an electronic stop signal.

In a further embodiment, the indication to the patient to bring the system back up includes a series of audible step instructions provided by the system to the patient. These step-wise instructions may be provided through a speaker connected to the system. In another embodiment, the indication to the patient to rejuvenate the system includes one or more visual instructions to the patient. Visual instructions may be provided in the manner described herein including, but not limited to, for example, a light or series of light indicators, a window providing a field of view into the system or container interior so that the user can identify the amount of medication remaining or administered, or a screen or display providing information regarding the amount of medication remaining or administered in the container.

In a further embodiment, the instructions to the patient to reconstitute the system include instructions to replace the first container with a second container and to activate the system to inject a calculated dose of medication substantially corresponding to the dose of medication remaining in the first container. In another embodiment, reconstitution of the system to complete a dose of medication includes providing the patient with an indication that he or she reinserts the injection component into the patient and activates the system to complete the dose of medication remaining in the container. In yet another embodiment, reconstitution of the system to complete a dose of medicament includes replacing the injection member and providing an indication to the patient indicating that it is inserting the injection member into the patient and activating the system to complete the dose of medicament remaining in the container.

In another embodiment, a medicament delivery system as described in embodiments of the present invention is provided, wherein information regarding the detection is provided to the system based on the output generated by the detection element while medicament continues to be delivered through the injection component. For example, if a wet injection is detected, the system is informed, but in one non-limiting embodiment, the injection continues.

For example, in one non-limiting embodiment, a drug delivery system is provided that includes a container for storing a drug prior to use, the container having a first end and a second end. An injection component is in fluid communication with the container, an advancement mechanism is coupled to the container and delivers the drug from the container through the injection component when the advancement mechanism is activated, and at least one detection element is coupled to the system, wherein the at least one detection element detects when the injection component is removed from the patient during administration of the drug through the injection component.

Referring to the drawings, FIG. 1 shows a cross-sectional view of one embodiment of the drug delivery system 10, including a propellant member 16 for activating the system 10, a speaker 24, a controller 22 and a container 12. The medicament delivery system 10 is in a first mode of operation and an injection component 14 is delivered from the container 12. A first spring 32 and a second spring 34 are loaded to cause the injection component 14 to be administered from the container 12 while simultaneously causing the piston 26 to move in a first direction relative to the second chamber 28 to administer the medicament in the container 12 through the injection component 14 based on output provided to the controller 22 from the sensing element (i.e., the contact sensor 20a) on the shroud 11. In one embodiment, the sensing element 20 may generally comprise an electromechanical element. The interconnection between propulsion mechanism 17, propulsion unit 16, controller 22 and the other various parts of the system, and the connectivity between them, is the same as described in U.S. patent application nos. 61788033, 14017933 and 61886596. Those skilled in the art will appreciate the interrelationship and functionality of the motors, controllers, propulsion mechanisms, and other parts of the system under the teachings of these patent applications. Those skilled in the art will also appreciate that the coupling between the various components of the system, including, for example, the sensing elements, the propulsion components, and the controller, may be by wireless means or by wired means as is known in the art. The piston 26 is shown in a second position within the container 12. A sensing element 20 is at a bottom end portion of the housing 11 of the system 10. In this embodiment, the sensing element comprises a touch sensor 20a, but in other embodiments may comprise a light sensor 20b (as shown in FIG. 2), or a temperature switch 20c (as shown in FIG. 3), as non-limiting examples.

The system 10 of fig. 1 provides a gate (33), wherein the gate 33 may be activated to stop movement of the piston based on output information received from the sensing element 20 and thereby prevent further administration of the drug through the injection component 14. This occurs, for example, in one embodiment, when a wet injection is detected by the system, in order to prevent the drug from being continuously delivered from the system without the injection member being inserted into the user. Thus, when a wet injection is detected by the detection element 20, the gate 33 snaps over the stem of the piston 26, preventing movement of the piston 26 relative to the second chamber 28, thereby preventing flow of the drug through the injection component 14.

Fig. 2 shows another embodiment of the system 10 having a hood 11 and a pushing mechanism 17, the pushing mechanism 17 being capable of being actuated by the pushing member 16. In the embodiment of fig. 2, propulsion mechanism 17 shows a motor and a drive handle assembly for driving movement of piston 26 relative to container 12 to control movement of piston 26 relative to second chamber 28 and movement of second chamber 28 relative to first chamber 30, or vice versa.

Fig. 2 provides a detection element embodied as a light sensor 20 b. The light sensor 20b is capable of detecting light emitted from the light source 46 when the container and/or shroud 11 is not in contact with a user. When the cover 11 is in contact with a target surface of the user, light emitted from the light source 46 is blocked from being detected by the light sensor 20 b. The light source 46 is shown in contact with the bottom surface of the housing 11; however, in one embodiment, the light source may be located on the interior or a portion of the container 12 such that the light source 46 emits light when a lower portion of the shroud 11 is not in contact with a surface of a user. In another non-limiting embodiment, the light sensor 20b can detect the reflection of light from the light source 46 on one surface of the user when the shroud 11 is not in contact with the surface of the user. In response to the light detected by light sensor 20b, system 10 generates an output to detect, or detect and prevent, or stop the delivery of the drug through injection member 14 to detect or detect and prevent a wet injection.

Fig. 2 comprises a locking mechanism 47, wherein the medicament is prevented from being administered through the injection member when the locking mechanism 47 is in a locked position. This prevention measure is responsive to output information generated by the at least one detection device, e.g. the light sensor 20 b. Thus, in one non-limiting example, the locking mechanism 47 may remain in a locked position if the light sensor 20b detects light from the light source 46 and/or light reflected from a surface from the light source 46.

Fig. 3 is a cross-sectional view of one embodiment of the system 10 having a housing 11, and a container 12 contained within the housing 11. The system 10 provides a controller 22 and a speaker 24, and a propulsion unit 16 coupled to the system 10. The propulsion mechanism 17 is actuated by the propulsion member 16, and the propulsion mechanism 17 is shown to include a motor and a drive handle assembly for driving movement of the piston 26 relative to the container 12. In the embodiment shown in fig. 3, a temperature switch 20c is located on a portion of the housing 11 for sensing the temperature of a surface to which the temperature switch 20c is attached. This is a non-limiting example of a method of detecting a wet injection by detecting whether the system 10 is removed from a surface of a user during an injection.

Fig. 4A-4B show the system 10 in a first mode of operation (fig. 4A) and a second mode of operation (fig. 4B) wherein the medicament 18 is in the container 12 of fig. 4A and the second spring 34 driving the piston 26 is loaded. In a first mode of operation of the system 10, as shown in fig. 4A, after the system 10 is activated by the propellant member 16, a medicament is administered through the injection member. In one non-limiting embodiment, second spring 34 has a greater resistance than first spring 32, which causes first spring 32 to be compressed before second spring 34 by activating propellant member 16, and injection member 14 to pass through first contamination barrier 29 in first chamber 30 (as shown in fig. 5) before drug 18 is administered from injection member 14. The system 10 is capable of compensating for the different forces required to inject the administered drug 18 using the system 10. In one embodiment, one force may be required to cause the system 10 to force the needle to penetrate the skin of the user, wherein another force is required to disperse/deliver the drug 18 through the system to the user. The present invention can be varied to compensate for these different forces. In one embodiment, springs of various resistances may be used. Based on an output generated by the sensing element (i.e., contact sensor 20d), system 10 may transition to a second mode of operation in which no drug is being administered through injection member 14, thereby preventing a wet injection, and in some embodiments, as shown in fig. 4B, injection member 14 retracts into first chamber 30 to prevent inadvertent contact with injection member 14.

In some embodiments, the detection and prevention of wet injection is based in part on the detection of the detection element 20 and in part on the first and second sensing elements. Fig. 4A-B provide a first sensing element 36 located on a portion of the system 10 and a second sensing element 38 coupled to the piston 26 such that the position of the piston 26 relative to the first sensing element 36 can be identified when the first sensing element 36 senses the position of the second sensing element 38 relative to the first sensing element. In a non-limiting embodiment, the second inductive element 38 may be an integral part of the piston or embedded in the piston. In a non-limiting embodiment, the first sensing element 36 can send an output to the system 10 or a user, including information regarding the position of the second sensing element 38, or vice versa. This information may be used to determine an amount of medicament 18 to be administered through the injection component 14, to determine whether a full or partial dose has been administered, and to determine the amount of the remaining dose to be administered to the user.

In the embodiment shown in fig. 4A-B, when the contact sensor 20d of the system 10 detects that contact between the user and the contact sensor 20d has been removed, the contact sensor 20d (an example of a sensing element 20) sends an output to the system. In one embodiment, when the first sensing element 36 senses a position of the second sensing element 38, the second sensing element is coupled to the piston 26, and the piston 26 is in a position between a first position and a second position, and the contact sensor 20d does not detect contact between the contact sensor 20d and the user, the system 10 can detect the occurrence of a wet injection, i.e., the injection is stopped by one of the methods described herein (i.e., the system switches to the second mode of operation). Methods of stopping the injection include, but are not limited to, activating the gate 33 to stop movement of the piston 26. For example, a signal may be sent to activate the brake, which can prevent movement of the piston 26. In one non-limiting embodiment, gate 33 may operate by grasping the shank of the piston to engage a portion (i.e., the shank) of piston 26 when a wet injection is sensed to have occurred or is about to occur. There are many different methods known in the art to stop or prevent the continued delivery of medicament through an injection component. Alternatively, the administration of the medicament may be stopped by stopping operation of the system 10. In other embodiments described in fig. 2-3, such as embodiments including a motor as part of propulsion mechanism 17, once a wet injection is detected, an output is sent to controller 22, and controller 22 then provides a stop output to propulsion mechanism 17.

Fig. 5 and 6 provide enlarged views of the container 12 showing the locations of the first 29, second 31 and third 33 anti-contamination barriers for sealing the container 12 and maintaining the sterility of the medicament in the container 12. Fig. 5 provides a sensing element 20 in the form of a sensor adjacent the injection component 14. The sensing element 20 provides an output based on the position of the sensing element 20 relative to a target area of the user. Based on the output information received from the sensing element 20, the system operates in either the first or second mode of operation. One embodiment of the visual indicator 40 is shown in fig. 6 as being located on the second chamber 28, such that a user is able to determine the amount of medicament within the container 12 through the visual indicator 40. Various embodiments of the visual indicator 40 are described further below.

Fig. 7-8 provide cross-sectional views that are used step-wise on one embodiment of the system 10 described herein. Fig. 7 and 8 provide an embodiment of a system 10 having a controller 22, a speaker 24, a propulsion member 16, a propulsion mechanism 17, a container 12, the container 12 having a first chamber 30 and a second chamber 28, a piston 26, a first loading member 32 positioned between the first chamber 30 and the second chamber 28, and a sensing element (contact sensor 20a) positioned on a portion of the chamber 11 of the system 10 for sensing contact between the contact sensor 20a and a surface (i.e., a target surface 42a of a user's target tissue 42).

Sensing elements

36, 38 are provided to detect the position of piston 26 during use of system 10, and can be used to detect the amount of drug remaining in container 12 during an injection, particularly if a wet injection is detected by system 10. Detecting the amount of drug remaining in the container 12 after a wet injection can provide information about the amount of drug remaining after a wet injection is detected, or detected and prevented, to the user. Fig. 7 shows a protruding member 45 attached to a lower portion of the cover 11 of the system 10. In one non-limiting embodiment shown in fig. 7, the protruding member 45 may be a sliding member that slides to cover an opening through which the injection member 14 protrudes from the container 12 to prevent unwanted contact with the injection member 14 when the container 12 is removed from the cover 11, causing a puncture wound. In fig. 8, the injection component 14 is shown retracted into the container 12 and the projecting component 45 covers the opening for injection to prevent the injection component from protruding therefrom and/or to prevent an object from entering through the opening and contacting the injection component 14. In other non-limiting embodiments, a portion of the protruding member 45 can be hinged to the cap to provide a passage for the injection member 14 to pass therethrough. Other mechanical means for closing the protruding members, FIG. 8 shows the system 10 removed from the user such that the contact sensor 20a is removed from the target surface 42a of the target tissue 42 of the patient, wherein a wet injection is detected or prevented by the system 10. Once a wet injection is detected, injection component 14 is retracted into container 12 to prevent injection component 14 from inadvertently puncturing the user and/or to maintain the sterility of injection component 14. This may be done by the loading member 32. The first and

second sensing elements

36, 38 are capable of sensing the position of each other to identify the amount of medicament being administered to the user and/or the amount of medicament remaining in the container 12.

After a wet injection is detected and prevented, the system 10 may provide instructions to the user to re-prime the system 10 to complete the injection. In one embodiment, such resumption may include restarting the system 10 by the advancement member 16, re-injecting the user at the target surface 42a of the target tissue 42 to complete the injection and deliver the remainder of the medicament to the user. In another embodiment, the reconstitution may be to remove a partially used container 12 and replace a new container 12 for the remainder of the drug to be administered. Determining the amount of drug remaining in the previously partially used container 12 after a wet injection is critical for system recovery and administration of the remaining portion of the drug after insertion of a new container 12 into the system 10. In another non-limiting embodiment, after a wet injection is detected and prevented, the partially used container 12 may be reused to complete the injection; however, the user may need to replace the used injection component 14 with a new injection component 14 before the injection is completed.

It is noted that all patents, patent applications, patent publications, technical publications, scientific publications, and other references cited herein are hereby incorporated by reference in order to more fully describe the art to which the invention pertains.

It is important to understand the present invention that, unless specifically defined herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. The techniques used in the present invention are also known to those skilled in the art, unless otherwise stated. To more clearly facilitate an understanding of the disclosure and claims herein, the lexical definitions are provided at the outset.

While various embodiments of the present invention have been shown and described in the present context, these embodiments are by way of example only, and not by way of limitation. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing substantially from the invention. For example, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include other embodiments falling within the scope of the present teachings. Furthermore, in the claims, any terms "method + function" and "step + function" are intended to cover the structures and acts described herein, respectively, for performing the recited function and are not only structurally identical or functionally identical, but are also structurally identical or functionally identical. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims, as interpreted in accordance with the relevant law.

Claims

1. A drug delivery system comprising:

a container for storing the medicament prior to use, said container having a first end and a second end;

an injection member in fluid communication with the container;

an advancement mechanism coupled to the container and configured to deliver the medicament from the container through the injection member when the advancement mechanism is activated; and

at least one sensing element coupled to the system;

wherein when the system is in a first mode of operation, medicament is administered through the injection component and when the system is in a second mode of operation, medicament is not administered through the injection component, and said mode of operation is dependent upon output information from said at least one sensing element such that if, upon said at least one sensing element and at least one first sensing element and one second sensing element, after said advancing mechanism is activated and before an injection is completed, said system detects removal of said container or said injection component from a target injection site and a medicament administration state when said container or said injection component is removed from said target injection site, an output is generated indicating that an incomplete medicament administration has occurred; and optionally, the first and second sensors may be,

When an incomplete drug delivery is detected, the system enters the second mode of operation, stopping drug delivery.

2. The medicament delivery system of claim 1, wherein the sensing element is associated with the injection component.

3. The medicament delivery system of claim 1, wherein the first sensing element senses a position of the second sensing element, and wherein the first sensing element generates an output.

4. The medicament delivery system of claim 3, wherein the mode of operation is dependent upon an output received from the at least one sensing element and the first sensing element.

5. The medicament delivery system of claim 1, further comprising a controller configured to monitor output information from the at least one sensing element, the controller configured to operate the system in the first mode of operation or the second mode of operation based on the received output information.

6. The medicament delivery system of claim 1, wherein the at least one sensing element comprises a contact sensor, wherein the output generated by the at least one sensing element is dependent on whether contact is made between the contact sensor and a target injection site.

7. The medicament delivery system of claim 1, wherein the at least one detection element comprises a light sensor and the output information is dependent upon whether a light beam is projected from the container.

8. The medicament delivery system of claim 1, wherein the at least one detection element comprises a temperature sensor, and the output information of the at least one detection element is dependent on a temperature at a target injection site detected by the temperature sensor.

9. The medicament delivery system of claim 8, wherein the system operates in the first mode of operation when the temperature sensor detects a temperature between 87-100 degrees fahrenheit.

10. The medicament delivery system of claim 8, wherein the system operates in the first mode of operation when the temperature sensor detects a temperature between 90-93 degrees fahrenheit.

11. The medicament delivery system of claim 1, wherein the at least one sensing element comprises a contact sensor and a temperature sensor, wherein the mode of operation of the system is dependent on at least one output generated by the at least one sensing element based on the contact sensor and the temperature sensor.

12. The medicament delivery system of claim 1, wherein the at least one detection element comprises a distance sensor to detect a distance of the system to a target injection site.

13. The medicament delivery system of claim 9, wherein the mode of operation is dependent on output information generated by the at least one detection element as a function of a distance of the system to a target area.

14. The medicament delivery system of claim 1, further comprising a valve that opens and closes based on the output generated by the at least one sensing element.

15. The medicament delivery system of claim 14, wherein when the valve is open, medicament is delivered through the injection member, and when the valve is closed, medicament delivery through the injection member is stopped.

16. The medicament delivery system of claim 1, wherein the injection member is coupled to the container such that when the advancement mechanism is activated, the injection member extends from the container and retracts into the container after use.

17. The medicament delivery system of claim 16, wherein the injection member extends from the container when the advancement mechanism is activated, and the system is in a first mode of operation.

18. The medicament delivery system of claim 16, wherein the injection member is retracted into the container when the system is in a second mode of operation.

19. The medicament delivery system of claim 18, further comprising a protruding member, wherein the protruding member obstructs the injection opening when the injection member is retracted into the container, thereby preventing the injection member from protruding from the opening.

20. The medicament delivery system of claim 1, wherein a locking mechanism is coupled to the propulsion mechanism, wherein the locking mechanism is activated based on an output from the at least one detection element.

21. The medicament delivery system of claim 1, wherein a locking mechanism is coupled to the propulsion mechanism, wherein the locking mechanism is activated based on the output generated by the at least one sensing element and the at least one first sensing element.

22. The medicament delivery system of claim 20, wherein when the locking mechanism is in a locked position, delivery of medicament through the injection member is prevented, and when the locking mechanism is in an unlocked position, medicament is delivered through the injection member.

23. The medicament delivery system of claim 1, further comprising a stopping mechanism, wherein the stopping mechanism is activated based on the output from the at least one sensing element and/or the at least one first sensing element, wherein the stopping mechanism is configured to stop the delivery of the medicament after the advancing mechanism is activated and before the delivery of the medicament is complete.

24. The medicament delivery system of claim 1, wherein the system is reset after the second mode of operation such that any remaining medicament in the container can be delivered through the injection component.

25. The medicament delivery system of claim 24, wherein the system is configured to reset after a predetermined period of time has elapsed after the second mode of operation.

26. The medicament delivery system of claim 22, wherein the locking mechanism is reset to the unlocked position after a predetermined period of time.

27. The medicament delivery system of claim 1, further comprising a current through the injection member such that the second mode of operation is initiated when a change in the electrical characteristic is detected.

28. The medicament delivery system of claim 27, wherein a change of a measurement unit on the injection member is detected by the detection element when the injection member is inserted into or removed from a target injection site, and wherein the mode of operation depends on a value of the unit.

29. The medicament delivery system of claim 1, wherein a controller electronically controls activation and/or deactivation of the advancement mechanism based on the output generated by the at least one detection element and/or the first sensing element.

30. The medicament delivery system of claim 1, further comprising an electrical current through the container, wherein the first sensing element is configured to sense an amount of medicament in the container.

31. The medicament delivery system of claim 1, further comprising a piston, wherein the piston interacts with the advancement mechanism such that when the advancement mechanism is activated, the piston passes through the reservoir from a first position of the piston to a second position of the piston, such that when the piston moves from the first position to the second position, medicament is delivered through the injection member.

32. The medicament delivery system of claim 31, wherein the second sensing element is coupled to the piston, and wherein the first sensing element senses the second sensing element and provides an output based on the first or second position of the piston relative to the container and/or any intermediate position of the piston therebetween.

33. The medicament delivery system of claim 32, wherein the second inductive element comprises a magnet.

34. The medicament delivery system of claim 32, wherein the piston comprises a Linear Variable Differential Transformer (LVDT).

35. The medicament delivery system of claim 32, wherein the first sensing element generates an output indicating an incomplete medicament delivery when the system is in a second mode of operation and the piston is between the first and second positions.

36. The medicament delivery system of claim 31, wherein a motor is configured to drive the system, a number of revolutions of the motor being indicative of the amount of medicament remaining in the container when the system is in a second mode of operation and the piston is between the first position and the second position.

37. The medicament delivery system of claim 28, wherein an amount of medicament remaining in the container is identified based on an amount of piston movement.

38. The medicament delivery system of claim 1, wherein the system further comprises a flow sensor for sensing the amount of medicament delivered by the injection member.

39. The medicament delivery system of claim 1, wherein the system comprises a visual indicator for indicating an amount of medicament in the container.

40. The medicament delivery system of claim 35, wherein after the second mode of operation, the system is reset wherein the container can be replaced.

41. The medicament delivery system of claim 37, wherein the advancement mechanism is activated when the container is replaced and the system is reset to begin the first mode of operation.

42. A drug delivery system comprising:

a container for storing a medicament prior to use, said container comprising:

a second chamber for storing the medicament;

a piston connected to the first chamber;

a first chamber, said second chamber being embedded in the first chamber;

an injection member connected to a lower end portion of the second chamber and movable in the second chamber through an injection opening;

A spring positioned between the first chamber and the second chamber;

at least one sensing element coupled to the container and providing an output based on a condition sensed by the at least one sensing element;

an advancing mechanism coupled to said system such that when the advancing mechanism is activated, said second chamber moves in a first direction relative to said first chamber, the spring is loaded, the injection member extends from said first chamber, the piston moves relative to said second chamber to administer the medicament through the injection member, such that when said second chamber moves in a second direction relative to said first chamber, the spring is released and the injection member retracts into said first chamber to prevent inadvertent contact with the injection member;

wherein in a first mode of operation of the system, medicament is administered through the injection component and in a second mode of operation of the system, medicament is not administered through the injection component, and the mode of operation is dependent upon output information emitted by the at least one sensing element such that if, upon actuation of the advancing mechanism and prior to completion of an injection, the system detects removal of the container or the injection component from a target injection site and detects incomplete medicament administration when the container or injection component is removed from the target injection site, an output is generated indicating that an incomplete medicament administration occurred, based upon the at least one sensing element and the at least one first and one second sensing elements; and optionally, the first and second sensors may be,

43. The medicament delivery system of claim 42, wherein the detection element is associated with the injection component.

44. The medicament delivery system of claim 42, further comprising an electrical current through the injection member such that the second mode of operation is initiated when a change in an electrical characteristic is detected.

45. The medicament delivery system of claim 44, wherein a change in a measurement unit on the injection component is detected by the detection element when the injection component is inserted into or removed from the target injection site, and wherein the mode of operation is dependent on a value of the measurement unit.

46. The medicament delivery system of claim 42, wherein in a first mode of operation, the advancement mechanism is activated and medicament is delivered through the injection member, and in a second mode of operation, the advancement mechanism is deactivated and delivery of medicament through the injection member is deactivated.

47. The medicament delivery system of claim 46, wherein after the second mode of operation of the system, the system is reset such that any remaining medicament in the container can be delivered through the injection component.

48. The medicament delivery system of claim 46, wherein the system is configured to reset after a predetermined period of time following the second mode of operation.

49. The medicament delivery system of claim 42, further comprising a controller configured to monitor output information from the at least one sensing element, the controller operating the system in one of the first or second modes of operation based on the received output information.

50. The medicament delivery system of claim 42, wherein the at least one sensing element comprises a contact sensor, wherein the output information provided by the at least one sensing element is dependent on whether contact is made between the contact sensor and a target injection site.

51. The medicament delivery system of claim 42, wherein the at least one detection element comprises a light sensor and the output information is dependent upon whether a beam of light is projected from the container.

52. The medicament delivery system of claim 42, wherein the at least one sensing element comprises a temperature sensor, and the output generated by the at least one sensing element is dependent on a temperature at the target injection site as sensed by the temperature sensor.

53. The medicament delivery system of claim 52, wherein the sensed skin temperature is between 87-100 degrees Fahrenheit.

54. The medicament delivery system of claim 52, wherein the sensed skin temperature is between 90-93 degrees Fahrenheit.

55. The medicament delivery system of claim 42, wherein the at least one sensing element comprises a distance sensor.

56. The medicament delivery system of claim 55, wherein the mode of operation of the system is dependent upon output information generated by the at least one sensing element based upon the distance of the system to a target injection site.

57. The medicament delivery system of claim 42, further comprising a valve configured to open and close based on the output generated by the at least one sensing element.

58. The medicament delivery system of claim 57, wherein when the valve is open, medicament is delivered through the injection member and when the valve is closed, medicament delivery through the injection member is stopped.

59. The medicament delivery system of claim 42, further comprising a protruding member, wherein the protruding member obstructs the injection opening when the injection member is retracted into the container, thereby preventing the injection member from protruding through the injection opening.

60. The medicament delivery system of claim 42, further comprising a locking mechanism having a locked position and an unlocked position, wherein when the system is in the first mode of operation, the locking mechanism is in the unlocked position to enable the propulsion mechanism to be activated, and when the system is in the second mode of operation, the locking mechanism is in the locked position to prevent activation of the propulsion mechanism.

61. The medicament delivery system of claim 49, wherein actuation of the advancement mechanism is electronically controlled by the controller based on the output generated by the at least one detection element.

62. The medicament delivery system of claim 42, further comprising a sensor coupled to the container to enable the amount of medicament in the container to be detected.

63. The medicament delivery system of claim 42, further comprising an electrical current directed through the container for sensing the amount of medicament in the container.

64. The medicament delivery system of claim 42, wherein the piston passes through the reservoir from a first position of the piston to a second position of the piston, such that medicament is delivered through the injection member when the piston moves from the first position to the second position.

65. The medicament delivery system of claim 64, further comprising at least a first sensing element, wherein the first sensing element senses and provides an output based on the first or second position of the piston relative to the container and/or any intermediate position of the piston therebetween.

66. The medicament delivery system of claim 65, wherein the system further comprises at least one second sensing element, wherein the second sensing element is sensed by the first sensing element.

67. The medicament delivery system of claim 65, wherein at least one of the first or second sensing elements is associated with the piston and the other of the first or second sensing elements is associated with a portion of a container.

68. The medicament delivery system of claim 65, wherein when the system is in the second mode of operation and the piston is between the first and second positions, an output is generated by the at least one sensing element indicating that an incomplete delivery of medicament has occurred.

69. The medicament delivery system of claim 68, wherein a motor is arranged to drive the system, and wherein a number of revolutions of the motor is indicative of the amount of medicament remaining in the container.

70. The medicament delivery system of claim 68, wherein the amount of medicament remaining in the container is identified based on an amount of piston displacement.

71. The medicament delivery system of claim 42, wherein the system further comprises a flow sensor for sensing the amount of medicament delivered by the injection member, wherein the amount of medicament remaining in the container can be identified based on the amount of medicament sensed by the flow sensor.

72. The medicament delivery system of claim 42, wherein the system comprises a visual indicator for indicating the amount of medicament in the container.

73. The medicament delivery system of claim 68, wherein after the second mode of operation, the system is reset wherein the container is replaced.

74. The medicament delivery system of claim 73, wherein the advancement mechanism is activated when the container is replaced and the system is reset to begin the first mode of operation.

75. The medicament delivery system of claim 42, further comprising a stopping mechanism, wherein the stopping mechanism is activated based on an output generated by the at least one sensing element, wherein the stopping mechanism is configured to stop the delivery of the medicament after the advancing mechanism is activated.

76. The medicament delivery system of claim 75, wherein the stopping mechanism is activated based on an output generated by the at least one sensing element and the at least one first sensing element, wherein the stopping mechanism is configured to stop the delivery of the medicament after the advancing mechanism is activated.

77. A medication delivery system, comprising:

an injection member in fluid communication with the container;

an advancing mechanism for advancing to initiate an injection; and

at least one sensing element associated with the system, the at least one sensing element for sensing a condition of the drug delivery system, wherein in a first mode of operation drug is delivered through the injection component and in a second mode of operation drug is not delivered through the injection component, such that if the system senses removal of the container or the injection component from a target injection site based on the at least one sensing element and at least one first and second sensing elements after the actuation of the advancing mechanism and before an injection is completed, a condition of a wet injection is sensed and an output is generated indicating incomplete drug delivery; and optionally, the first and second sensors may be,

When the condition of one wet injection and one incomplete administration of the drug is detected, the system enters the second mode of operation, stopping the administration of the drug.

78. The medicament delivery system of claim 77, wherein the one condition comprises the injection member being removed from the user during administration of the medicament through the injection member.

79. The medicament delivery system of claim 77, wherein the system stores information about the detected condition.

80. The medicament delivery system of claim 77, wherein the sensing element senses contact between the medicament delivery system and a user such that the sensing element generates an output based on the sensed contact.

81. The medicament delivery system of claim 77, wherein the sensing element senses the amount of medicament remaining in the container and/or the amount of medicament delivered through the injection member when the injection member is not in the target injection position, thereby sensing an incomplete medicament delivery and/or a remaining dose for a complete delivery.

82. The medicament delivery system of claim 77, further comprising an advancement mechanism associated with the container, wherein the medicament is delivered from the container through the injection member when the advancement mechanism is activated.